Siemens Symbia Intevo SPECT/CT Systems Recalled for Rubber Isolator Aging
Siemens Medical Solutions is recalling 48 Symbia Intevo SPECT/CT systems because a rubber isolator may degrade over time, potentially leading to drive belt rupture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical component degradation that could lead to drive belt rupture, representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is performing a field correction on 48 Symbia Intevo series SPECT/CT systems, including the Intevo 16, Intevo 6, Intevo 2, and Intevo Excel models. The recall is due to a rubber isolator within the rotate motor mounting assembly that has unfavorable aging properties. This component may degrade over time, which could impact motor support.
The affected systems were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations. The source text notes that while the isolator degradation does not pose a hazard by itself, it could lead to a rupture of the drive belt. The provided text is truncated and does not specify further consequences or specific instructions for consumers beyond the field correction.
The recalled product
- Product
- The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping.…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Symbia Intevo Excel
- Product Code: 10764801
- Serial Numbers: 1001
- 1002
- 1003
- 1004
- 1005
- 1006
- 1007
- 1008
- 1009
- 1010
- 1011
- 1012
- 1013
- 1014
- 2) Symbia Intevo 2
- Product Code: 10764802
- 2001
- 3) Symbia Intevo 6
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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